Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LifeScan
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- BG results of 3 BGMSs vs LifeScan reference instrument ( YSI 2300)
研究概览
简要总结
This study is to evaluate accuracy between product platforms in the hands of users, comparing capillary to venous response vs YSI reference instrument as well as the local hospital analyser.
详细描述
This study will gather data to:
- Determine if extreme bias can be observed between 3 candidate products for user accuracy.
- Assess the offset between venous blood samples versus capillary blood samples.
- Determine if there are measurable donor factors which influence the product bias.
- Assess any offset between YSI 2300 reference instruments and hospital laboratory analyser and impact on bias difference between BGM product types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Summary of Inclusion Criteria:
- •Male or Female subjects with T1DM or T2DM.
- •Must be able to read and sign the approved consent form.
- •Registered into the LifeScan patient registry.
- •Currently performing self monitoring of blood glucose ( SMBG)
排除标准
- •Conflict of Interest - Prospective Participants will be excluded from enrollment if they are currently working for, have previously worked for, or have an immediate family member working for a company that manufactures or markets the type of products tested under the scope of this procedure.
结局指标
主要结局
BG results of 3 BGMSs vs LifeScan reference instrument ( YSI 2300)
时间窗: Within 24 hours
Blood glucose result on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus.) compared to LifeScan's reference instrument ( YSI 2300) using venous and capillary blood.
Comparison of blood glucose ( BG) results between 3 LifeScan blood glucose monitoring systems ( BGMS).
时间窗: Within 24 hours
Comparison of Blood glucose results between 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus.) using capillary and Venous blood samples.
BG results of 3 BGMSs vs hospital's laboratory biochemistry analyser.
时间窗: Within 24 hours
Blood glucose result on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus.) compared to hospitals own laboratory biochemistry analyser using venous blood.
Venous blood collected for impact assessment of Biochemistry parameters on 3 LifeScan Blood Glucose Monitoring Systems (OneTouch Ultra 2, OneTouch Verio, OneTouch SelectPlus).
时间窗: Within 24 hours
The following biochemistry parameters were analysed in mmol/l: Calcium, adjusted calcium, Chloride, Glucose, Potassium, Sodium, Triglycerides, urea, urate, Total Co2
次要结局
未报告次要终点